Electromed (ELMD) Announces U.S. Food and Drug Administration 510(k) Clearance of Fifth Generation HFCWO Airway Clearance Generator ELMD:
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Electromed, Inc. (NYSE American: ELMD) a leader in innovative airway clearance technologies, today announced that it received U.S Food and Drug Administration (“FDA”) 510(k) clearance of the SmartVest® Clearway® Airway Clearance System, which is designed for High Frequency Chest Wall Oscillation (“HFCWO”) therapy. The SmartVest Clearway system, an updated and modern approach to HFCWO, offers an enhanced patient experience with proven patient outcomes.1
“It is our goal to make home airway clearance easier and more convenient for patients, while continuing to provide a superior product, proven outcomes, and outstanding patient service,” commented Kathleen Skarvan, President and Chief Executive Officer of Electromed. “SmartVest Clearway meets these goals with its intuitive touch screen, the lightest weight generator on the market, and smaller footprint than our previous generation which continues our history of innovation in HFCWO therapy. We are proud to further our mission and assist more patients to breathe easier and improve their quality of life.”
The SmartVest Clearway system uses HFCWO, a clinically proven therapy that helps clear the lungs of excess secretions, thereby reducing the risk of respiratory infections and hospitalizations for those suffering from a chronic lung condition.1 HFCWO delivers alternating pulses of air into a vest garment that rapidly compresses and releases the chest wall, resulting in an oscillation in airflow within the airways that acts to loosen, thin, and propel mucus toward the major airways where it can be expectorated. The SmartVest Clearway Airway Clearance System is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest System is indicated when external chest manipulation is the physician’s treatment of choice to enhance mucus transport. HFCWO therapy is often prescribed for illnesses such as non-cystic fibrosis bronchiectasis (NCFB) and other chronic pulmonary conditions.
Limited market release of the device in the U.S. will begin in the coming weeks.
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